ANTIBODY-DRUG CONJUGATES: FUNDAMENTALS, DRUG DEVELOPMENT, AND CLINICAL OUTCOMES TO TARGET CANCER

• Part I What is an Antibody–Drug Conjugate 1
1 Typical Antibody–Drug Conjugates 3
• Part II Engineering, Manufacturing, and Optimizing Antibody–Drug Conjugates 33
2 Selecting Optimal Antibody–Drug Conjugate Targets Using Indication-Dependent or Indication-Independent Approaches 35
3 Antibody–Drug Conjugates: An Overview of the CMC and Characterization Process 59
4 Linker and Conjugation Technology; and Improvements 85
5 Formulation and Stability 105
6 QC Assay Development 131
7 Occupational Health and Safety Aspects of ADCs and Their Toxic Payloads 151
• Part III Nonclinical Approaches 177
8 Bioanalytical Strategies Enabling Successful ADC Translation 179
9 Nonclinical Pharmacology and Mechanistic Modeling of Antibody–Drug Conjugates in Support of Human Clinical Trials 207
10 Pharmacokinetics of Antibody–Drug Conjugates 245
11 Path to Market Approval: Regulatory Perspective of ADC Nonclinical Safety Assessments 267
• Part IV Clinical Development and Current Status of Antibody–Drug Conjugates 285
12 Antibody–Drug Conjugates: Clinical Strategies and Applications 287
13 Antibody–Drug Conjugates (ADCs) in Clinical Development 321
14 ADCs Approved for Use: Trastuzumab Emtansine (Kadcyla®, T-DM1) in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer 345
15 ADCs Approved for Use: Brentuximab Vedotin 381
16 Radioimmunotherapy 409
• Part V Future Perspectives in Antibody–Drug Conjugate Development 431
17 Radiolabeled Antibody -Based Imaging in Clinical Oncology 433
18 Next-Generation Antibody–Drug Conjugate Technologies 473

Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells.
• Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies
• Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging
• Includes case studies of ADCs in oncology drug development
• Features contributions from highly-regarded experts on the frontlines of ADC research and development

Author Information
• Kenneth J. Olivier, Jr., PhD, is Head of Toxicology, Discovery Regulatory, Bioanalytical Assay Development, Pharmacokinetics and Discovery Project Management at Merrimack Pharmaceuticals and has over 13 years’ experience in the biotechnology and pharmaceutical industries.
• Sara A. Hurvitz, MD, is an Associate Professor of Medicine at the University of California, Los Angeles (UCLA); Co-Director of the Santa Monica-UCLA Outpatient Oncology Practice; Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center of UCLA; and Director of the Breast Oncology Program, Division of Hematology-Oncology, at UCLA.